Comparison of Pain Therapeutic Effects After Benign Mastectomy

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether can find one way to relief the postoperative pain after such operation is still unknown. We hypothesized that the pain from the relatively small surgery may not be significant compared with different treatments, even...

Date First Received: August 21, 2007

Last Updated: April 18, 2008

Verified by: Nanjing Medical University, April 2008

Clinical Trial Phase: Phase 4 | Start Date: February 2007

Overall Status: Completed

Estimated Enrollment: 2000

Brief Summary

Official Title: “Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy”

Condition Keyword(s):

With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether can find one way to relief the postoperative pain after such operation is still unknown. We hypothesized that the pain from the relatively small surgery may not be significant compared with different treatments, even no drug was delivered to them.So then we are enrolling patients who underwent mastectomy from benign breast tumor, and observing the analgesic effects of different drugs.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Outcome Measures for this Clinical Trial

Primary:

  • Visual analog scale (VAS) rating of pain 0-24h after surgeries Yes

Secondary:

  • VAS rating of sedation 0h to 24h after the end of the operation Yes
  • Overall VAS rating of satisfaction with analgesia At the end of the study Yes
  • Incidence of side effects From the initiation of analgesia to the end of the study Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Chinese
  • No cardiac and pulmonary diseases
  • ASA I-II
  • No alcohol drinking.

Exclusion Criteria:

  • <19yrs, and >65yrs
  • History of central active drugs administration
  • Drug abuse
  • Hypertension
  • Diabetes
  • Any other chronic diseases.

Clinical Trials Locations, Contact Details, and Sponsors

Lead Sponsor: Nanjing Medical University

Nanjing Maternal and Child Care Hospital

Nanjing Jiangsu 210004 China

Overall Clinical Trial Officials and Contacts

XiaoFeng Shen, MD Study Chair Nanjing Medical University  

Additional Information

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00519246

Study ID Number: NMU-2579-4FW

ClinicalTrials.gov Identifier: NCT00519246

Health Authority: China: Ministry of Health

Clinical Trials Authorship and Review

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